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Background Information on the Authorisation Procedure

Here you will find information and forms relating to an application for authorisation of a biocidal product.

An application for authorisation must satisfy various requirements, which are described in the documents below. Furthermore you are provided assistance with compiling the necessary application documents.

Information on the authorisation of biocidal products

There are fact sheets relating to all of the different application types within the framework of the Biocidal Products Regulation. They explain the requirements for the respective applications and provide answers to frequently asked questions.

Fact sheets are available for the following application types:

  • National authorisation
  • Mutual recognition (in parallel/in sequence)
  • Authorisation of a same biocidal product (in parallel/in sequence)
  • Change of an authorisation of a biocidal product (administrative/minor/major)

Other fact sheets provide assistance with the following topics:

  • Identification of biocide residues in food and feed
  • Authorisation numbers for biocidal product families

More fact sheets (in German language) can be found on our German Website.

Application documents

Depending on the type of application, further documents may be required for submitting the application in Germany.

The corresponding application documents are compiled in the following zip-file:

Application documents for authorisation of biocidal products (FileTypex-zip-compressed, 3MB)

Common best practice code for the application of anticoagulant rodenticides

In Germany, there is a defined common best practice code for the application of anticoagulant rodenticides (active substances that inhibit the clotting of the blood). This is a condition for authorisation of all anticoagulant rodenticides.

As such, it is an integral part of the respective authorisation of a biocidal product, legally binding and must be adhered to by all users.

Please note: the only relevant information for the user is that found on the label and in the instructions for use of the respective biocidal product that is to be used. These instructions must strictly be followed.

The corresponding criteria can be found below.

More corresponding criteria (in German language) can be found on our German Website.

First generation anticoagulants

First generation anticoagulants

Biocidal products with first generation anticoagulants include all rodenticides containing the active substances warfarin, chlorophacinone and coumateralyl.

In addition, the following provisions apply:

  • For expert users and expert professional users: the "Common best practice code for the application of feed baits in rodent control using anticoagulant rodenticides by specialised and licensed professionals" (revised: 25 Mar 2013)
  • For non-expert users: the "General criteria for the correct application of feed baits in rodent control using anticoagulants by non-expert users" (revised: 19 June 2013)

In any case, the only provisions relevant for the user are those of the authorisation, communicated on the label and in the instructions for use of the respective biocidal product.

Second generation anticoagulants

Second generation anticoagulants

Biocidal products with second generation anticoagulants include all rodenticides containing the active substances difenacoum, difethialone, bromadiolone, brodifacoum and flocoumafen.

In the review of the "Common best practice code for the application of feed baits in rodent control using anticoagulant rodenticides", it was established, with regard to the prohibition on permanent baiting (irrespective of an infestation) using second generation anticoagulants, that permanent baiting of this kind (irrespective of an infestation) may be necessary in special sensitive areas (e.g. food businesses) in order to protect the health or safety of humans and animals.

For this reason, the Federal Office for Chemicals has established a derogation in cooperation with the Risk Assessment Units. This allows permanent baiting (irrespective of an infestation) under certain conditions, provided a trained or certified pest controller with expert knowledge in accordance with Annex I Number 3 of the Hazardous Substances Ordinance establishes that these conditions are met in a specific individual case.

Accordingly, the existing conditions for second generation anticoagulants have been revised and adapted. The use of biocidal products containing second generation anticoagulants is therefore subject to the following regulation:

"Common best practice code for the application of feed baits in rodent control using anticoagulant rodenticides by specialised and licensed professionals" (Version 1.3 of 30 July 2014)

In the case of the authorisations already issued for second generation anticoagulants, it was left up to the authorisation holders to adopt this change for their products.

In any case, the only provisions relevant for the user are those of the authorisation , communicated on the label and in the instructions for use of the respective biocidal product.

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